Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma

This study has been terminated.
(IRB Study Closure)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00365222
First received: August 15, 2006
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days.

Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.

The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.

Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.


Condition Intervention Phase
Glioblastoma
Gliosarcoma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Evaluate overall survival [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival at six and nine months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Response rate measured by a reduction in tumor size [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Quality of life measured at each cycle utilizing the QOL FACT-BR [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Temozolomide
temozolomide 75 mg/m2 /d
Other Name: Temodar

Detailed Description:

A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Temozolomide will be administered orally (a capsule) at approximately the same time daily (bedtime) for 42 days on and then 14 days off; cycles may be repeated every 56 days. Complete blood counts will be obtained bi-weekly, evaluations monthly and MRI's every 2 months after a cycle of therapy.

Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast (all disease found at staging must be followed using the same modality used at Pre-treatment. Tumor assessments are to be repeated every 56 days thereafter until progression). The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment.

Patients may continue on therapy unless one of the following occurs:

  • Documented or clinical progressive disease at any time
  • Unacceptable toxicity
  • Treatment delay of > 2 weeks for any reason
  • Study data or other data indicate that the study treatment is not beneficial for the patients; defined as at least one response in the first 12 patients within each tumor histology strata
  • Non-compliance by the patient with protocol requirements (follow-up, treatment, administration of disallowed therapy)
  • Changes in medical status of the patient such that the patient no longer meets eligibility requirements (leptomeningeal spread, change in mental competency) or the investigator believes that patient safety will be compromised.
  • Patient withdrawal of consent for treatment
  • Occurrence of one toxic death

Patients with CR, PR, or stable disease (SD) will be treated for a minimum of 3 cycles [6 months] or until disease progression. For patients responding to treatment, continuation of therapy beyond 3 cycles is at the discretion of the investigator. Response parameters will include the MacDonald criteria for evaluating brain tumors. Response is measured by a reduction in tumor size.

After cessation of protocol therapy, patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histological documented glioblastoma or gliosarcoma. All patients must have had prior pathologic confirmation of tumor histology.
  • Patients must be > than or equal to 70 years old.
  • Patients must have a Karnofsky performance status of > 50.
  • Nonmeasurable disease or measurable disease per MacDonald criteria
  • Patients must have a predicted life expectancy of at least 12 weeks.
  • Required initial laboratory data: ANC >1,500, Platelets >100,000, Serum Creatinine <2.0, Serum Bilirubin <2.0, and AST/ALT <3x normal
  • Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).
  • Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
  • Patients must have been previously treated with surgery.
  • No prior adjuvant or salvage chemotherapy regimen is permitted.
  • Prior radiotherapy is not permitted.

Exclusion Criteria:

  • Patients have evidence of leptomeningeal spread of disease.
  • Patients having been treated with prior chemotherapy or radiotherapy.
  • Patients with a second active malignancy or diagnosis of other cancer within -3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
  • Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
  • Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
  • Known to be HIV positive or to have an AIDS-related illness.
  • Patients with an active infection that is not adequately controlled with antibiotics.
  • Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Patients with a known sensitivity to any of the products to be administered during treatment.
  • Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
  • Patients previously treated with temozolomide.
  • Concurrent radiotherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365222

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Schering-Plough
Investigators
Principal Investigator: Marc Chamberlain, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Marc Chamberlain, M.D., H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00365222     History of Changes
Other Study ID Numbers: MCC-14714
Study First Received: August 15, 2006
Last Updated: January 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Temozolomide
Temodar
Glioblastoma
Gliosarcoma
Brain Tumor
Quality of Life
Neurological

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014